- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03713411
Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?
Is Routine Urinary Bladder Catheterization Necessary After Ureteroscopy and Double J Stent Placement?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ureteral stents and foley catheters are the most commonly used disposables in urological practice. Ureteral double J (DJ) stents are frequently used to relieve ureteral obstruction and almost as a routine part of the ureteroscopic procedures by many surgeons.
DJ stent placement has the potential side effects such as flank pain and urinary tract infection (UTI) due to retrograde urine flow. As the bladder pressure increases during voiding, urine reflux occurs both beside and through the DJ stent. In order to overcome these problems, stents with antireflux mechanisms are produced, however these new stents comes with higher costs compared to conventional stents.
Foley catheters are the hands and feet of all urologists and insertion of a foley catheter can easily keep the bladder pressures as low as required. The practice of insertion of a foley catheter into the urinary bladder after ureteroscopy for kidney or renal stones and DJ stent placement doesn't have an evidence-based background and it routinely depends on the choice of the surgeon.
The aim of this study is to evaluate whether routine insertion of a bladder catheter following ureteroscopy and DJ stent placement can reduce stent-related problems due to reflux and urinary tract infections.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yiloren Tanidir, Assc. Prof.
- Phone Number: 905325694275
- Email: yiloren@yahoo.com
Study Contact Backup
- Name: Tarik Emr Sener, M.D.
- Phone Number: +5337620712
- Email: dr.emresener@gmail.com
Study Locations
-
-
-
Istanbul, Turkey, 34890
- Marmara University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adult patients
- Patients with indications for semirigid or flexible ureteroscopy and DJ stent placement for unilateral ureteral and/or kidney stones according to European Association of Urology Urolithiasis Guidelines
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No-catheter
after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones, patients in whom a urethral catheter wasn't placed
|
|
Active Comparator: Catheter
urethral catheter placement after semirigid or flexible ureteroscopy + double J stent placement for ureteral or kidney stones
|
urethral catheter placement to provide low-pressure urinary bladder by providing active drainage of the bladder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ureteric stent symptom questionnaire (USSQ) score
Time Frame: at the 24th hour of the operation
|
evaluation of flank pain
|
at the 24th hour of the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
white blood cell count on complete blood count
Time Frame: at the 24th hour of the operation
|
evaluation of laboratory test results for infectious parameters
|
at the 24th hour of the operation
|
c-reactive protein (CRP) levels
Time Frame: at the 24th hour of the operation
|
evaluation of laboratory test results for infectious parameters
|
at the 24th hour of the operation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tarik Emre Sener, MD, Marmara University Hospital, Department of Urology
- Study Chair: Yiloren Tanidir, Marmara University Hospital, Department of Urology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAR.UAD.004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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